Clearance Summary
FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K945519, sponsored by Pharmaquest Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1995-11-03.
- Submission: K945519
- Applicant / Sponsor: Pharmaquest Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1505
- Decision date: 1995-11-03
Classification & Regulation
This clearance is catalogued under FDA product code MPG and 21 CFR 862.1505, within the Clinical Chemistry review panel as a Class I device.